Rational treatment selection for Merkel Cell Carcinoma (MCC)
ISRCTN | ISRCTN16290169 |
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DOI | https://doi.org/10.1186/ISRCTN16290169 |
Secondary identifying numbers | 20444 |
- Submission date
- 09/03/2016
- Registration date
- 09/03/2016
- Last edited
- 10/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English Summary
Contact information
Public
University of Birmingham
Institute for Cancer Studies
Edgbaston
Birmingham
B15 2TT
United Kingdom
Phone | +44 121 414 3792 |
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rationalmcc@trials.bham.ac.uk |
Study information
Study design | Multi-centre phase III randomised parallel trial |
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Primary study design | Interventional |
Secondary study design | Randomised parallel trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
Scientific title | Rational treatment selection for Merkel Cell Carcinoma (MCC): A randomised phase III multi-centre trial comparing radical surgery and radical radiotherapy as first definitive treatment for primary MCC with an observational study for patients ineligible for the randomised trial. |
Study hypothesis | The aim of this study is to determine if radical surgery or radical radiotherapy as first definitive treatment for the primary merkel cell carcinoma (MCC) results in better control of loco-regional disease. |
Ethics approval(s) | 15/WM/0454 |
Condition | Merkel cell carcinoma |
Intervention | Participants are randomised to one of two study arms. Arm A - Prioritise surgery: WLE of the primary site with radiotherapy reserved for later adjuvant treatment in selected patients. Arm B - Prioritise radiotherapy: Early use of radical radiotherapy to the primary site without prior radical surgery. |
Intervention type | Procedure/Surgery |
Primary outcome measure | Time from randomisation to loco-regional treatment failure is determined from data collected throughout the study and up to 2 years of follow-up. |
Secondary outcome measures | 1. Progression free survival 2. Proportion of patients alive and free of disease 3. Quality of Life is measured at baseline, 3, 6, 9, 12 and 24 months from randomisation; 4. Survival 5. Time to distant progression 6. Time to local failure 7. Time to regional nodal failure |
Overall study start date | 31/03/2016 |
Overall study end date | 30/09/2020 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | Planned Sample Size: 400; UK Sample Size: 400 |
Participant inclusion criteria | General inclusion criteria for all patients: 1. Patients newly diagnosed with histologically-proven MCC (either primary and/or regional nodal disease) 2. Completion of clinical and radiological staging investigations, including CT imaging (or other modality) of regional nodal basin(s) and major viscera (and SLNB if clinically appropriate) to identify regional and distant metastases 3. No distant metastases beyond the regional nodal basin (i.e. not stage IV disease) 4. Being considered for radical treatment to achieve long term disease control 5. Able to give valid informed consent 6. Consent for collection of data and tissue samples and follow up. 7. Life expectancy six months or greater in relation to general fitness and co-morbidities Additional inclusion criteria for rational compare: 1. Patients newly diagnosed with histologically-proven primary MCC 2. In the opinion of the SSMDT, the primary MCC can be encompassed both within a wide surgical margin and within a radiotherapy field, and the SSMDT is in equipoise regarding WLE or radiotherapy as first treatment 3. Consent for randomisation into Rational Compare |
Participant exclusion criteria | Exclusion criteria for rational compare only: 1. The primary MCC has already been treated radically with WLE (surgical margins >10 mm) or RT 2. Intended use of regional or systemic chemotherapy (including molecularly targeted agents and immunotherapy) |
Recruitment start date | 31/03/2016 |
Recruitment end date | 30/12/2018 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Edgbaston
Birmingham
B15 2TT
United Kingdom
Sponsor information
Hospital/treatment centre
Cancer Research UK Clinical Trials Unit
Edgbaston
Birmingham
B15 2TT
England
United Kingdom
https://ror.org/03angcq70 |
Funders
Funder type
Research council
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
Intention to publish date | 14/03/2022 |
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Individual participant data (IPD) Intention to share | Yes |
IPD sharing plan summary | Other |
Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Protocol file | version 4.0 | 11/01/2019 | 10/10/2022 | No | No |
HRA research summary | 28/06/2023 | No | No |
Additional files
Editorial Notes
10/10/2022: Protocol file uploaded.
09/03/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/03/2021 to 30/12/2018.
2. The overall end date was changed from 30/03/2021 to 30/09/2020.
3. The intention to publish date was changed from 30/03/2022 to 14/03/2022.
4. The publication and dissemination plan was added.
5. The participant level data sharing plan was added.
09/07/2020: The trial contact details have been made publicly visible.
02/04/2019: The condition has been changed from "Topic: Cancer; Subtopic: Cancer (Melanoma); Disease: Cancer (Melanoma)" to "Merkel cell carcinoma" following a request from the NIHR.
01/11/2017: Internal review.
28/10/2016: Cancer Help UK lay summary link added.